FDA Revokes MQSA Certificate of California Mammography Facility

Facility was subject of previous FDA Safety Notification on poor mammogram quality; patients who received mammograms on or after Sept. 8, 2014, advised to have results re-evaluated elsewhere

March 30, 2016 — The U.S. Food and Drug Administration (FDA) revoked the Mammography Quality Standards Act (MQSA) certificate of J. Bruce Jacobs M.D. Inc., doing business as Huntington Radiology in Huntington Park, Calif., on March 4. The FDA is alerting patients who had mammograms at the facility any time on or after Sept. 8, 2014, about possible problems with the quality of their mammograms.

This facility was the subject of a prior FDA Safety Notification issued on March 10, 2011.

The American College of Radiology (ACR) conducted a review of mammograms performed at the facility between Sept. 8, 2014, and Nov. 4, 2014. The clinical image review was conducted for the purposes of accreditation reinstatement following the Aug. 31, 2010, ACR revocation of the facility’s accreditation. On Sept. 8, 2014, the facility was provisionally certified to provide mammography services; however, a subsequent ACR clinical image review indicated problems with the quality of the mammography at the facility. The ACR revoked the facility's application for accreditation effective Feb. 20, 2015, and the FDA suspended the facility’s certificate on March 6, 2015.

On April 8, 2015, the FDA required the facility to notify all patients who received mammograms at its facility any time on or after Sept. 8, 2014, and their referring healthcare providers, about the problems with the mammography quality at the facility.

In accordance with its rules and requirements the State of California, Health and Human Services Agency, California Department of Public Health issued a Cease and Desist Order against the facility on Feb. 9, 2015, based on a state investigation and the findings noted by the ACR during the Additional Mammography Review (AMR).

Under the MQSA of 1992, the FDA requires that all mammography facilities meet certain baseline quality standards and be certified to legally operate in the United States. This facility did not meet standards for mammography quality under the Act. The facility may not legally perform mammography at this time due to the suspension of its certificate.

This does not mean that the results of the mammograms were inaccurate, but it does mean that the patients should consider having their mammograms re-evaluated at an MQSA-certified facility to determine if the patients need a repeat mammogram or additional medical follow-up.

The FDA will continue to monitor this issue and keep the public informed as new information becomes available.